RU2662338C2 - Tooth whitening composition for oral hygiene - Google Patents

Abstract

FIELD: hygiene.

SUBSTANCE: group of inventions refers to the field of oral hygiene products and methods of using them. Present tooth whitening composition for oral hygiene includes: (I) flakes of a water-soluble whitening film that includes (a) a film forming polymer containing hydroxypropylmethylcellulose, a viscosity of 2 % solution at 20 °C and 10 s^-1 which is 4–6 MPa⋅s, as measured using a Ubbelohde capillary viscometer; and (b) a pigment of blue or bluish-violet color, with a color tone in the CIELAB system ranging from 220 to 320 degrees; and (II) an orally acceptable carrier. And the particle size of the film flakes is such that more than 90 % of the particles pass through a 30–50 mesh filter. Method for temporary whitening of teeth is also provided, comprising applying an effective amount of the above composition to the oral cavity of a subject to which this is required.

EFFECT: use of a group of inventions ensures the effective deposition of said pigment on the surface of the teeth, which leads to an increase in whiteness of the teeth.

14 cl, 6 tbl, 3 ex

Description

[1] Many people are not satisfied with the color of their teeth. Therefore, there is a need to have whiter teeth, and one way to achieve this is to use teeth whitening products.

[2] It is known from the literature that visual perception can be changed by applying an optical brightener, a blue pigment or a blue dye, especially one for which the angle of the color tone (on the CIELAB scale) of reflected or emitted light is in the range from 200 to 320 degrees. This effect is usually used in washing powders, so that white clothing on the eye appears “whiter”. The same concept is used for whitening teeth. It is possible to make the natural off-white or yellow color of the teeth be perceived more white by applying a blue substance to the teeth. The use of pigments with deposition stimulants in toothpaste, i.e. high molecular weight polymers such as Gantrez® (copolymers of maleic anhydride and methyl vinyl ether) to make teeth look whiter, disclosed in European patent 1935395 B1.

[3] There is a need to create tooth whitening oral hygiene products containing pigments and polymers other than Gantrez®, which, when incorporated into oral hygiene products, would generate an superior temporary tooth whitening effect.

SUMMARY OF THE INVENTION

[4] A teeth whitening composition for oral hygiene, comprising:

(i) scraps of a water-soluble whitening film that contains

(a) a film-forming polymer containing hydroxyalkyl cellulose, wherein the viscosity of the hydroxyalkyl cellulose is from about 1 to less than 1000 millipascals seconds (mPa⋅s) as determined for an aqueous solution with a polymer concentration of 2% by weight at 20 ° C. using a Ubbelohde capillary viscometer ; and

(b) a pigment having a blue to bluish-violet color with a color tone angle in the CIELAB system in the range of 200 to 320 degrees, where the film is preferably free of starch and where the clumps have a dissolution rate of about 30 seconds or less, and

(ii) an orally acceptable carrier.

[5] Other fields of application of the present invention will be apparent from the following detailed description. It should be understood that the detailed description and specific examples, although indicating preferred embodiments of the invention, are illustrative only and are not intended to limit the scope of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[6] The following description of a preferred embodiment (s) of the invention is, in fact, merely an example, and is not intended to limit the invention, its uses or uses.

[7] The term "does not contain starch" means that starch was not added to the film-forming ingredients, and the resulting film does not contain a measurable amount of starch.

[8] The film forming polymer comprises a hydroxyalkyl cellulose polymer.

In one embodiment of the invention, the film-forming polymer consists mainly of a hydroxyalkyl cellulose polymer, in other words, there are no other polymers forming it, such as starch or Gantrez®.

[9] In accordance with the present invention, there is provided an oral composition, for example, a dentifrice, which contains pieces of a water-soluble film suspended in it (sometimes referred to herein as “film pieces”), consisting of a mixture, usually homogeneous, water-soluble a hydroxyalkyl cellulose polymer and a film matrix with a pigment that has a color from blue to purple and a color tone angle in the CIELAB system in the range from 200 to 320 degrees.

[10] In the preparation of film scraps in accordance with the present invention, hydroxyalkyl cellulose and pigment were dissolved in a compatible solvent (eg, water, ethyl acetate, acetone or alcohol, such as ethanol, or mixtures thereof) to create a film forming composition. Optionally, other ingredients may be added, for example, a flavoring agent, a humectant (e.g., propylene glycol), a surfactant (e.g., Tween 80), a sweetener, an active substance, and the like. Optional ingredients may be present in the film, in the non-film portion of the oral composition, or in both of these parts, a more detailed description of such optional ingredients is provided below. The film-forming composition was applied to a carrier with the possibility of subsequent removal and dried to form a sheet of film matrix material. The material of the carrier should have a surface tension that allows the film solution to be evenly distributed over a given width of the carrier, without absorption, with the formation of a destructive bond between the substances of the film and the carrier. Examples of suitable carrier materials include glass, stainless steel, Teflon, and polyethylene-impregnated paper. Drying of the film can be carried out at high temperature, using a drying oven, drying terminal, vacuum dryer, or any other suitable drying equipment that does not adversely affect the ingredients that make up the film.

[11] The film thickness varies from about 0.0254-0.127 mm (1-5 mils), or about 0.254-0.102 (1-4 mils), or about 0.038-0.127 mm (1.5-5 mils), or about 0.038-0.76 mm (1.5-3 mil), or about 0.051-0.076 mm (2-3 mil), or about 0.051 mm (2 mil).

[12] After the formation of the film, film shreds are made of it, for example, by perforating or cutting the film into shreds of various shapes, such as hearts, squares, rectangles, triangles, stars, diamonds, circles, etc. Optionally, the film can be milled into irregular shapes using conventional grinding equipment known in the art. Typically, film fragments are so large that more than 90% of the particles pass through a 50 mesh filter. In some embodiments of the invention, the particle size allows them to pass through the filter between 30 and 100 mesh, or between 30 and 80 mesh, or between 50 and 80 mesh. Scraps of the film are introduced into the oral composition of the present invention in a concentration of from about 0.05 to 5.0% by weight, in one embodiment of the invention from about 0.05 to 2%, in another embodiment of the invention from about 0.05 to 1 % and in another embodiment of the invention from about 0.1 to about 0.5% by weight.

[13] Scraps of the film according to the invention have a high dissolution rate, for example, about 30 seconds or less, in another embodiment, from about 1 to 30 seconds, in another embodiment of the invention from about 1 to 25 seconds, in another embodiment of the invention from about 1 to 20 seconds, in another embodiment of the invention from about 2 to 15 seconds. The dissolution rate is the average time it takes for the film fragments to break apart and release the observable pigment in the presence of water at room temperature, for example, 20-25 ° C. Typically, the dissolution rate can be determined in clinical trials involving 8 or more subjects using toothpaste containing film fragments and obtain an average dissolution rate.

[14] The film-forming agent that is used to prepare the film matrix of the present invention is a water-soluble hydroxyalkyl cellulose such as hydroxypropyl methyl cellulose, hydroxyethylpropyl cellulose and hydroxybutyl methyl cellulose. The term “alkyl” in this context means C _1-4 alkyl. The film-forming cellulose polymer is a low viscosity polymer. Low viscosity refers to a viscosity in the range of about 1 to less than about 1000 millipascals seconds (mPa⋅s), which is defined as the viscosity of an aqueous solution with a polymer concentration of 2% by weight at 20 ° C. using a Ubbelohde capillary viscometer. In a more particular embodiment of the invention, the viscosity of the polymer is from about 1 to about 100, more specifically from about 1 to about 20, and in a particular embodiment of the invention from about 1 to about 10 mPa · s at 20 ° C. In a preferred embodiment of the invention, the hydroxyalkyl cellulose polymer is a hydroxypropyl methyl cellulose (HPMC) polymer.

[15] HPMC is supplied by the Dow Chemical Company under the trade name Methocel E5 LV. Methocel E5 LV is an HPMC of pharmaceutical purity and low viscosity, having 29.1% methoxy groups and 9% substitution with hydroxypropyl groups. It is a white or off-white loose powder. When measuring viscosity using a Ubbelohde capillary viscometer, an aqueous solution with a concentration of 2 mass. % has a viscosity of 5.1 MPa · s at 20 ° C.

[16] Hydroxyalkyl cellulose is introduced into the film in amounts that range from about 10 to about 80% by weight, preferably from about 30 to about 60% by weight of the film. The hydroxyalkyl cellulose polymer is usually incorporated into the oral composition at a concentration of from about 0.01 to 10%, more often from about 0.05 to 5%, and most often from 0.1 to 1% by weight.

[17] Scraps of the film usually contain from about 0.01 to 5%, more often from about 0.015 to 5%, more often from about 0.015 to 3% of the oral composition of the invention.

[18] In use, the film matrix of the present invention is dissolved in water or an aqueous solution, such as saliva. During brushing, mechanical action contributes to the destruction of scraps of film, and this accelerates their dissolution in the aquatic environment.

[19] The amount of pigment in the oral composition is from 0.01 to 0.3%, more specifically from 0.02 to 0.1%, and even more specifically from 0.03 to 0.08% by weight. The pigment may be uniformly distributed throughout the composition or it may be dispersed in a second phase, such as a strip or other coextruded second phase. Such "biphasic" compositions have the advantage that the phases can be colored differently, presenting a more attractive product to the consumer.

[20] The color of the pigment is purple or blue, preferably one of those listed in Color Index International. These pigments are listed in this list at positions from pigment violet 1 to pigment violet 56 and from pigment blue 1 to 83. Examples of violet pigments are pigment violet 1, 1: 1, 1: 2, 2, 3, 5: 1, 13, 19, 23, 25, 27, 31, 32, 37, 39, 42, 44, and 50. Examples of blue pigments are blue pigment 1, 2, 9, 10, 14, 15, 15: 1, 15: 2, 15: 3, 15: 4, 15: 6 16, 18, 19, 24: 1, 25, 56, 60, 61, 62 and 66. Other suitable pigments are ultramarine blue and ultramarine violet. The pigment should have a hue angle, h, in the CIELAB system in the range of 200 to 320 degrees, more specifically, between 250 and 290 degrees. A detailed description of the hue angle can be found on page 57 of the Color Chemistry 3rd edition by H. Zollinger published by Wiley-VCH. Although the preferred individual pigments are blue and purple, the same effect can be achieved by mixing pigments that are not in this range of h; for example, such a hue angle can also be obtained by mixing red and cyan pigments to produce cyan or cyan pigment with an imperceptible transition into purple. Typically, the pigment is Pigment Blue 15, more specifically, Pigment Blue 15: 1, 15: 2, 15: 3, 15: 4, 15: 5 or 15: 6. Typically, a pigment is capable of reflecting enough light so that the treated tooth is perceived as whiter than its original color. Preferably, the pigment is colored so that its natural color is between violet-red and green-blue, usually between violet and blue. If a red pigment is used, then it is usually present in a mass ratio of red pigment: blue pigment from about 0.1: 1 to about 1: 1. Examples of red pigment include Red 30, Red 40, and the like.

[21] A pigment is usually a shade / material that is insoluble in the medium used at the temperature used. In this, it differs from dyes, which, on the contrary, are soluble. In the context of the present invention, the “medium used” is human saliva, a liquid medium in which the composition is used, at an oral temperature during brushing, i.e. up to 37 ° C. As a satisfactory approximation, the medium used can be considered as water, and the temperature used as 25 ° C.

[22] In the context of the present invention, "soluble" hydroxyalkyl cellulose is a material that is soluble in water, usually its solubility at 25 ° C is 0.5% by weight or more, more often 5% or more. Further, such a material remains soluble after drying - i.e. after drying, it can be re-dissolved. Such materials are film forming polymers. Solubility in water is necessary to avoid polymer buildup on the teeth.

[23] The hydroxyalkyl cellulose polymer is used as a precipitation promoter, in other words, it contributes to the deposition of pigment on the teeth and thereby contributes to the color change caused by the pigment.

[24] Hydroxyalkyl cellulose in the film scraps promotes the deposition of pigment on the teeth so that the whiteness of the tooth surface increases by at least 20% or more, preferably at least 100%, compared with values obtained for teeth treated in an equivalent manner a control composition in which the same amount of pigment was used in the absence of hydroxyalkyl cellulose. A method for determining tooth whiteness is described in the Examples.

[25] Delta b * indicates the amount of color change along the yellow-blue axis, negative b * corresponds to a decrease in yellowness.

[26] Orally acceptable carrier

[27] Oral hygiene compositions of the invention include a carrier or base into which pieces of film are embedded. Examples of orally acceptable carriers include carrier polymers, humectants, water, abrasives, silica gel thickeners, or any combination of two or more of these substances. The term "orally acceptable" refers to a polymer or ingredient that can be used in relation to the oral cavity in a safe manner during normal use.

[28] Carrier Polymers

[29] Carrier polymers may include one or more anionic or nonionic polymers, as well as additional polymers to control the viscosity of the composition or increase the solubility of the remaining ingredients.

[30] Suitable carrier polymers include polyethylene glycols, polysaccharides (for example, cellulose derivatives, for example carboxymethyl cellulose, or polysaccharide resins, for example xanthan gum or carrageenan). Acidic polymers, for example polyacrylate gels, can be introduced in the form of their free acids, or partially or completely neutralized with water, soluble alkali metal salts (e.g. potassium and sodium) or ammonium salts. Anionic polymers useful in the context of this invention can enhance the effects of insoluble whitening complexes, for example, in an amount of from about 0.001 to about 5%, more specifically, from about 0.01 to 5%, even more specifically, from about 0.05 to 4%, even more specifically, from about 0.05 to 3% of the composition. Such agents are known, mainly, as used in dentifrices, although not for this specific purpose, but useful for this invention are disclosed in US patent No. 5188821 and No. 5192531; they include synthetic anionic polymeric polycarboxylates, such as copolymers of 1: 4 to 4: 1 maleic anhydride or an acid with another polymerizable ethylenically unsaturated monomer, preferably methyl vinyl ether / maleic anhydride, which has a molecular weight (MW) of about 30,000 to about 1,000,000, most preferably from about 300,000 to about 800,000. These copolymers can be purchased, for example, under the brand name Gantrez®., For example, AN 139 (MW 500000), AN 119 (MW 250,000) and, preferably, S-97 Pharmaceutical Grade (MW 700000), which is supplied by ISP Technologies, Inc., Bound Brook, NJ 08805. Other active polymers include substances such as 1: 1 copolymers of maleic anhydride with ethyl acryl atom, hydroxyethyl methacrylate, N-vinyl-2-pyrrolidone or ethylene, the latter being marketed, for example, under the names Monsanto EMA No. 1103, M.W. 10000 and EMA Grade 61, and copolymers of 1: 1 acrylic acid with methyl or hydroxyethyl methacrylate, methyl or ethyl acrylic atom, isobutyl vinyl ether or N-vinyl-2-pyrrolidone. Suitable are generally polymerized olefin or ethylenically unsaturated carboxylic acids containing an activated carbon-carbon olefinic double bond and at least one carboxyl group, in other words, acids containing an olefinic double bond that readily enter into polymerization because a monomeric ether molecule in the alpha-beta position relative to the carboxyl group or as part of a terminal methylene group. Illustrations of such acids are acrylic, methacrylic, ethacrylic, alpha-chloroacrylic, crotonic, beta-acryloxypropionic, sorbic, alpha-chlorosorbic, cinnamon, beta-styrylacrylic, muconic, itaconic, citraconic, mesaconic, glutaconic, alpha-2, acon benzyl acrylic, 2-cyclohexyl acrylic, angelic, umbelic, fumaric, maleic acids and anhydrides. Various other olefin monomers suitable for copolymerization with such carboxylic monomers include vinyl acetate, vinyl chloride, dimethyl maleate, and the like. The copolymers contain enough carboxyl salt groups for solubility in water. The next class of polymer agents includes compositions containing homopolymers of substituted acrylamides and / or homopolymers of unsaturated sulfonic acids and their salts, in particular when the polymers are based on unsaturated sulfonic acids selected from acrylamidoalkanesulfonic acids, such as 2-acrylamide 2 methylmethylpropanesulfonic acid, the molecular weight of which ranges from about 1000 to about 2,000,000, described in US patent No. 4842847, Jun. 27, 1989 to Zahid, which is incorporated herein by reference. Another useful class of polymeric agents includes polyamino acids, which contain portions of anionic surfactant amino acids such as aspartic acid, glutamic acid and phosphoserine (in addition to basic amino acid polymers), for example, as described in US Pat. No. 4,866,161 to Sikes et al., Incorporated to this document by reference.

[31] When preparing compositions for oral hygiene, it is sometimes necessary to add a certain amount of thickener to provide the desired consistency or to stabilize or improve the characteristics of the composition. In certain embodiments of the invention, the thickeners are carboxyvinyl polymers, carrageenan, hydroxyethyl cellulose and water soluble cellulose ether salts such as sodium carboxymethyl cellulose and sodium carboxymethyl hydroxyethyl cellulose. Hydroxyalkyl methyl cellulose may also be present in the non-film portion of the oral composition. Natural gums such as karaya gum, gum arabic and tragacanth gum can also be introduced into it. To further improve the texture of the composition, colloidal magnesium aluminosilicate or finely divided silica can be used as a component of the thickening composition. In certain embodiments of the invention, thickeners are used in an amount of about 0.05% to 5%, more specifically, about 0.5 to 5% of the total weight of the composition. Orally acceptable carrier polymers for use in this invention are usually soluble in water. Suitable orally acceptable carrier polymers for use in this invention will generally dissolve or disperse in water at a temperature of 25 ° C. In addition to the hydroxyalkyl methyl cellulose in the film scraps, certain orally acceptable carrier polymers are also able to promote deposition of pigment on the teeth so that the whiteness of the tooth surface increases.

[32] The amount of orally acceptable carrier polymers in the compositions of the invention, regardless of whether they are enhancers, deposition stimulants, thickeners or the like, or a combination thereof, meets the requirements when in the range of about 0.001 to 10% more specifically, from about 0.005 to 5%, even more specifically, from about 1 to 5%, and even more specifically, from about 1 to 3%.

[33] Humidifiers

[34] In certain embodiments of oral compositions, it is also desirable to administer moisturizers to prevent the composition from hardening when exposed to air. Certain humectants may also give the toothpaste compositions the desired sweetness or aroma. A humectant that is administered only for hydration typically ranges from about 15% to about 70% in one embodiment of the invention, or from about 30% to about 65% in another embodiment, by weight of the toothpaste composition. Suitable humectants include edible polyhydric alcohols such as glycerin, sorbitol, xylitol, propylene glycol, as well as other polyols and mixtures of these humectants. In certain embodiments of the invention, mixtures of glycerol and sorbitol can be used as moisturizing components of the toothpaste compositions described herein.

[35] Abrasives

[36] The compositions of the invention, for example, Composition 1 and subsequent, can include calcium phosphate abrasive, for example tricalcium phosphate (Ca ₃ (PO ₄ ) ₂ ), hydroxyapatite (Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ ) or dicalcium phosphate dihydrate (CaHPO ₄ ⋅ 2H ₂ O), sometimes also referred to herein as DiCal), or calcium pyrophosphate. The compositions may include one or more additional abrasives, for example, silica abrasives, such as precipitated silica with an average particle size of up to 20 microns, such as Zeodent 115®, supplied by J.M. Huber. Other useful abrasives also include sodium metaphosphate, potassium metaphosphate, aluminum silicate, calcined alumina, bentonite or other silicon-containing materials, or combinations thereof. The silica-based polishing abrasives effective in the present invention, like other abrasives, generally have an average particle size of between about 0.1 and about 30 microns, between about 5 and about 15 microns. Silicon-containing abrasives can be made from precipitated silica or silica gels, such as silica-based xerogels described in US Pat. No. 3,538,230 to Pader et al. and US Pat. No. 3,862,307, to Digiulio, both of which are incorporated herein by reference. Specific silica-based xerogels are sold under the trade name Syloid® by WR Grace & Co., Davison Chemical Division. Precipitated silica materials include those supplied by J.M. Huber Corp. under the trademark Zeodent®, including silica labeled Zeodent 115 and 119. These silica abrasives are described in US Pat. No. 4,340,583, to Wason, incorporated herein by reference. In certain embodiments of the invention, abrasive materials effective in the practice of oral hygiene compositions of the present invention include silica gels and precipitated amorphous silica having an oil absorption coefficient of less than about 100 cubic meters. cm / 100 g of silicon dioxide and in the range of about 45 cubic meters. cm / 100 g to about 70 cubic meters. cm / 100 g of silicon dioxide. Oil absorption coefficients were measured using the ASTA Rub-Out Method D281. In certain embodiments of the invention, the silica-based materials are colloidal particles whose average size is from about 3 microns to about 12 microns and from about 5 to about 10 microns. Silicon dioxide abrasives with a low oil absorption coefficient, particularly effective in the practice of the invention, are sold under the trade name Sylodent XWA® by Davison Chemical Division of WR Grace & Co., Baltimore, Md. 21203. Sylodent 650 XWA®, a silicate hydrogel consisting of colloidal silica particles with a water content of 29% by weight, with an average diameter of from about 7 to about 10 microns and with an oil absorption coefficient of less than about 70 cubic meters. cm / 100 g of silica is an example of a silica abrasive with a low oil absorption coefficient effective in the practice of the present invention. The abrasive is present in the oral hygiene composition of the present invention in a concentration of from about 10 to about 60% by weight, in another embodiment of the invention from about 20 to about 45% by weight, and in yet another embodiment of the invention from about 30 up to about 50% by weight.

[37] Water

[38] Water may also be present in the oral compositions of the invention. Water used in the manufacture of commercial oral compositions must be deionized and free of organic impurities. Water usually completes the balance of the compositions and is contained in an amount of from about 0.1% to about 90%, from about 10% to about 80%, or from about 20% to about 70%, or from about 30% to about 60%, mass of oral compositions. This amount includes added free water plus the amount that is added with other materials, such as sorbitol or any of the components of the invention. In one embodiment of the invention, no water is added at all.

[39] Release form

[40] Examples of suitable release forms for the compositions of the invention include dentifrices, oral rinses, chewing gums and lozenges.

[41] A typical release form of the present invention is a dentifrice. The term "dentifrice" usually refers to compositions that are used to clean surfaces in the oral cavity. A dentifrice is an oral composition that is not intended to be swallowed for the systemic administration of drugs, it is used in the oral cavity to treat it, and then spit out. Typically, a dentifrice is used together with a cleaning device such as a toothbrush, typically using a toothbrush bristle, and then the accessible surfaces of the oral cavity are cleaned. Preferably, the dentifrice is in the form of a paste or gel (or a combination thereof).

[42] Another type of release form in the context of the present invention is an oral rinse. The term “mouthwash” generally refers to liquid formulations that are used to rinse the surfaces of the oral cavity and give the user a feeling of cleanliness and freshness in the mouth. The oral rinse is an oral composition not intended for swallowing for the systemic administration of drugs, it is used in the oral cavity to treat it, and then spit out. The oral rinse composition of the present invention typically contains a uniform aqueous phase. The amount of water usually varies from 70 to 99% by weight of the total mass of the mouth rinse.

[43] Active substances

[44] The effective concentration of the active ingredients for optional use in the present invention will depend on the particular agent and the delivery system used. It is understood that toothpaste, for example, after use, will usually be diluted with water, while mouthwash will usually not be diluted. Therefore, the effective concentration of the active agent in toothpaste will usually be 5-15 times higher than in a mouth rinse. The concentration will also depend on the particular salt or polymer selected. For example, if the active agent is supplied in salt form, the mass of salt will depend on the counterion so that the heavier the counterion, the greater the mass of salt will be required to provide the same concentration of active ion in the final product. Active agents may include one or more sources of fluoride ions, an anti-calculus agent, an amino acid, a bleaching agent, a bactericidal agent, and the like.

[45] Arginine, if present, can be at levels, for example, from about 0.1 to about 20% of the mass, (expressed as the mass of the free base), for example, from about 0.1 to about 3% of the mass, for rinse aid mouth, from about 1 to about 10% of the mass, for consumer toothpaste or from about 7 to about 20% of the mass, for a professional or prescribed treatment and prophylactic agent. Fluoride, if present, can be at levels, for example, from about 25 to about 25,000 ppm, for example from about 25 to about 250 ppm for mouthwash, from about 750 to about 2,000 ppm for consumer toothpaste, or from about 2000 to about 25,000 ppm for a professional or prescribed therapeutic agent.

[46] Bactericidal agents, in particular non-cationic halogenated diphenyl ethers, the presence of which is desirable for reasons of efficacy and safety, such as 2 ', 4,4' trichloro-2 hydroxy-diphenyl ether (Triclosan) can be included in the oral composition of the present invention and 2,2'-dihydroxy-5,5 'dibromophenyl ether. The bactericidal agent, if present in the oral composition, is in concentrations from about 0.05 to about 2% by weight and preferably from 0.1 to about 1% by weight. The levels of bactericidal agents can vary similarly for toothpaste, for example, they can be from about 5 to about 15 times more than those used in a mouthwash. For example, a triclosan mouthwash may contain, for example, about 0.03% by weight of triclosan, while a triclosan toothpaste may contain about 0.3% by weight of triclosan.

[47] Substances that are used to reduce tooth sensitivity, such as potassium chloride, potassium nitrate and potassium citrate can also be included in the oral compositions of the present invention in concentrations from about 0.1 to about 10% by weight.

[48] Whitening products

[49] The bleaching agents that may be present in the oral composition include peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates, and combinations thereof. Suitable peroxide compounds include hydrogen peroxide, percarbamide, calcium peroxide, and mixtures thereof. Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite and potassium chlorite.

[50] Source of fluoride ions

[51] Compositions for oral hygiene may further include one or more sources of fluoride ions, for example, soluble fluoride salts. In the present compositions, a wide range of materials generating fluoride ions can be used as sources of soluble fluorides. Examples of suitable fluoride ion generating materials are found in US Pat. No. 3,535,421 to Briner et al .; U.S. Patent No. 4,885,155, to Parran, Jr. et al. and in US patent No. 3678154, to Widder et al., which are incorporated herein by reference. Typical sources of fluoride ions include, but are not limited to, tin fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, aminofluoride, ammonium fluoride, and combinations thereof. In certain embodiments of the invention, the source of fluoride ions includes tin fluoride, sodium fluoride, sodium monofluorophosphate, as well as mixtures thereof. In certain embodiments of the invention, the oral hygiene compositions of the invention may also contain a source of fluoride ions or a fluoride-containing ingredient in amounts sufficient to supply from about 25 ppm to about 25,000 ppm of fluoride ions, usually at least about 500 ppm, for example, from about 500 to about 2000 ppm, for example, from about 1000 to about 1600 ppm, for example, about 1450 ppm The appropriate level of fluoride will depend on the particular application. Toothpaste for use by a general consumer can typically contain from about 1000 ppm to about 1500 ppm, and children's toothpaste is slightly less. A dentifrice or professional coating may contain fluoride in an amount of about 5,000, or even about 25,000 ppm. Sources of fluoride ions can be added to the compositions of the invention at a level of from about 0.01% to about 10% by weight. in one embodiment of the invention or from about 0.03% of the mass. up to about 5% of the mass., and from about 0.1% of the mass. up to about 1% of the mass. by weight of the composition in another embodiment of the invention. Obviously, the masses of fluoride salts to provide a suitable level of fluoride ions will vary depending on the mass of the counterion in the salt.

[52] Frothers

[53] Compositions for oral hygiene according to the invention may also include substances to increase the amount of foam that is formed when cleaning the oral cavity. Illustrative examples of foam enhancing agents include, but are not limited to, polyoxyethylene and certain polymers, including, but not limited to, alginate polymers. Polyoxyethylene can increase the amount of foam and the thickness of the foam generated by the oral hygiene carrier component of the present invention. Polyoxyethylene is also commonly known as polyethylene glycol ("PEG") or polyethylene oxide. Polyoxyethylenes suitable for the present invention should have a molecular weight of from about 200,000 to about 7,000,000. In one embodiment, the molecular weight is from about 600,000 to about 2,000,000 and in another embodiment of the invention from about 800,000 to about 1,000,000. High molecular weight polyoxyethylene produced Union Carbide, has the Polyox® trademark. Polyoxyethylene may be present in an amount of from about 1% to about 90%, in one embodiment of the invention, from about 5% to about 50%, and in another embodiment of the invention, from about 10% to about 20% by weight of a carrier component of a substance for oral hygiene in the oral hygiene compositions of the present invention. The dose of blowing agent in the oral hygiene composition (i.e., a single dose) is from about 0.01 to about 0.9% by weight, from about 0.05 to about 0.5% by weight, and in another embodiment inventions - from about 0.1 to about 0.2% by weight.

[54] Anti-calculus preparations

[55] An oral composition may include at least one anti-tartar agent, such as one or more anti-tartar compositions provided in US Pat. No. 5,292,526, entitled "Bactericidal oral anti-plaque and tartar compositions", which is incorporated herein. by reference. In various embodiments of the invention, the anti-calculus composition comprises one or more polyphosphates. The anti-tartar composition may include at least one fully or partially neutralized alkali metal or ammonium tripolyphosphate, or hexametaphosphate salt present in the oral composition in an amount effective against tartar. The anti-tartar composition may also include at least one water-soluble, linear, molecularly dehydrated polyphosphate salt in an amount effective against tartar. The anti-tartar composition may also include a mixture of potassium and sodium salts, at least one of which is present in an amount effective against tartar, as a polyphosphate anti-tartar agent. The anti-tartar composition may also contain an effective anti-tartar amount of an anti-tartar agent containing a linear, molecularly dehydrated polyphosphate salt, in a mixture with sodium and potassium salts. Other useful anticalculus agents include polycarboxylate polymers and polyvinyl methyl ether / maleic anhydride (PVME / MA) copolymers such as GANTREZ. RTM

[56] Surfactants

[57] Compositions effective in this invention may contain anionic and / or nonionic surfactants, for example:

i. water-soluble salts of higher monosulfates of fatty acid monoglycerides, such as the sodium salt of a monosulphonated monoglyceride of hydrogenated coconut oil fatty acids, such as N-methyl N-cocoyl sodium taurate, sodium cocomonoglyceride sulfate,

ii. higher alkyl sulfates such as sodium lauryl sulfate,

iii. higher alkyl ether sulfates, for example, of the formula CH ₃ (CH ₂ ) _m CH ₂ (OCH ₂ CH ₂ ) _n OSO ₃ X, where m is 6-16, for example 10, n is 1-6, for example, 2, 3 or 4 , and X is Na or K, for example, laureth-2 sodium sulfate (CH ₃ (CH ₂ ) ₁₀ CH ₂ (OCH ₂ CH ₂ ) ₂ OSO ₃ Na),

iv. higher alkylaryl sulfonates, such as sodium dodecylbenzenesulfonate (sodium laurylbenzenesulfonate),

v. higher alkyl sulfoacetates such as sodium lauryl sulfoacetate (sodium dodecyl sulfoacetate), higher fatty acid esters of 1,2 dihydroxypropane sulfonate, sulfocolaurate (potassium sulfoacetamide N-2-ethyl laurate) and sodium lauryl sarcosinate.

[58] The term “higher alkyl” means, for example, C ₆ alkyl. ₃₀ . In specific embodiments of the invention, the anionic surfactant is selected from sodium lauryl sulfate and sodium lauryl sulfate ester. Anionic surfactants may be present in an amount that is effective, for example> 0.01% by weight of the composition, but not in a concentration that will irritate the tissues of the oral cavity, for example, <10%, and the optimal concentration depends on the specific composition and a particular surfactant. For example, the concentrations that are used in a mouthwash are usually an order of magnitude lower than in a toothpaste. In one embodiment, the anionic surfactant is present in the toothpaste at a concentration of from about 0.3% to about 4.5% by weight, for example, about 1.5%.

[59] Non-ionic surfactants include non-anionic polyoxyethylene surfactants such as Polyoxamer 407, Stearet 30, Polysorbate 20 and PEG-40 castor oil and amphoteric surfactants such as cocamidopropyl betaine (tegobain) and cocamidopropyl betaine, betaine, lauryl, glucoside condensation products of ethylene oxide with various reactive hydrogen-containing compounds having long hydrophobic chains (for example, aliphatic chains containing from about 12 to 20 atomic carbon), wherein these condensation products (“ethoxamers”) contain a hydrophilic polyoxyethylene function, such as condensation products of poly (ethylene oxide) with fatty acids, fatty alcohols, fatty amides and other fatty compounds, propylene oxide and polypropylene oxide (for example, Pluronic materials. RTM )

[60] The compositions of the invention may optionally contain mixtures of surfactants, for example, containing anionic surfactants and other surfactants, which may be anionic, cationic, zwitterionic or nonionic. In general, surfactants are more or less stable over a wide pH range. Surfactants are described in more detail, for example, in US patent No. 3959458, Agricola et al .; U.S. Patent No. 3,937,807 to Haefele; and in US patent No. 4051234, Gieske et al., which are incorporated herein by reference. In certain embodiments of the invention, surfactants effective in the present invention include water-soluble salts of alkyl sulfates having from about 10 to about 18 carbon atoms in the alkyl radical and water-soluble salts of sulfonated fatty acid monoglycerides having from about 10 to about 18 carbon atoms. Examples of this type of anionic surfactants are sodium lauryl sulfate, sodium lauroyl sarcosinate and sodium coconut monoglyceride sulfonates. In a specific embodiment, the composition of the invention, for example, Composition 1 onwards, comprises sodium lauryl sulfate.

[61] A surfactant or mixture of compatible surfactants may be present in the compositions of the present invention in an amount of from about 0.1% to about 5.0%, in another embodiment, from about 0.3% to about 3.0% and in yet another embodiment, from about 0.5% to about 2.0% by weight of the total composition.

[62] Flavors

[63] Oral hygiene compositions of the invention may also include a flavoring. Flavors that are used in the practice of the present invention include, but are not limited to, essential oils, as well as various flavoring aldehydes, esters, alcohols and similar materials. Examples of essential oils include peppermint, peppermint, gaulteria, sassafras, cloves, wormwood, eucalyptus, oregano, cinnamon, lemon, lime, grapefruit and orange oils. Chemicals such as menthol, carvone and anethole are also useful. In certain embodiments of the invention, peppermint and spearmint oils are used. The flavoring agent may be incorporated into the oral composition at a concentration of from about 0.1 to about 5% by weight, from about 0.5 to about 1.5% by weight. The dose of flavoring in the dosage of an individual oral hygiene composition (i.e., a single dose) is from about 0.001 to 0.05% by weight, and in another embodiment, from about 0.005 to about 0.015% by weight.

[64] Other optional ingredients

[65] In addition to the components described above, embodiments of the invention may contain a variety of optional dentifrice ingredients, some of which are described below. Optional ingredients include, for example, but are not limited to, adhesives, blowing agents, sweeteners, and additional coloring agents. These and other optional components are described in more detail in US patent No. 5004597, to Majeti; U.S. Patent No. 3,959,458 to Agricola et al. and in US patent No. 3937807, to Haefele, all of these patents are incorporated herein by reference.

[66] As is customary everywhere, ranges are used as a condition that everything and every value that is within a range will be described. Any value within the range can be selected as the limit of the range. In addition, all references cited in this document, thereby include in its entirety all the information presented in these materials. If there is a conflict in the use of a word or term in the present description and documents that may be incorporated into this description by reference, the definitions corresponding to the present description should be adopted.

[67] Unless otherwise indicated, all percentages and amounts indicated in this document and elsewhere in the document refer to percent by weight. The quantities shown are based on the active weight of the material. For convenience, the components of the composition of the invention are expressed in the singular; however, it should be understood that the use of the singular also encompasses mixtures of components, for example, an “orally acceptable carrier polymer” may include mixtures of two or more of the polymers described herein.

[68] The invention also includes a method for temporarily whitening teeth, which comprises administering an effective amount of a composition of the invention to the oral cavity of a subject in need thereof. The whitening effect of the composition is considered temporary in the sense that its whitening effect will noticeably decrease within two weeks after application, if there is no additional processing. [69] Thus, the invention provides, in a first embodiment, an oral composition (Composition 1) that contains (i) patches of a water-soluble whitening film containing (a) a film-forming polymer containing hydroxyalkyl cellulose, wherein the hydroxyalkyl cellulose has a viscosity of about 1 up to less than about 1000 millipascals seconds (mPa⋅s), as determined for a 2% by weight aqueous polymer solution at 20 ° C using a Ubbelohde capillary viscometer; and (b) a pigment having a blue to violet color with a color tone angle in the CIELAB system in the range of 200 to 320 degrees, wherein the dissolution rate of the film fragments is about 30 seconds or less, (ii) an orally acceptable carrier; eg,

1.1. Composition 1, wherein the hydroxyalkyl cellulose is hydroxypropyl methyl cellulose;

1.2. Composition 1, in which the pigment has a color tone angle in the CIELAB system in the range from 220 to 290 degrees;

1.3. Any of the compositions described above, wherein the pigment is a blue pigment such as Blue 15;

1.4. Any of the compositions described above, wherein the film does not contain starch;

1.5. Any of the compositions described above, wherein hydroxyalkyl cellulose has a viscosity of from about 1 to about 100, or about 1 to about 10 millipascal seconds (mPa · s) as determined for 2% by weight of an aqueous polymer solution at 20 ° C. using a Ubbelohde capillary viscometer;

1.6. Any of the compositions described above, where the film fragments contain from 0.01 to 5%, more typically from about 0.015 to 5%, more specifically from 0.015 to 3% of the composition of the invention;

1.7. Any of the compositions described above, wherein the pigment contains from about 0.1 to 20%, more specifically from about 1 to 10%, and even more specifically from about 2 to 8% of the oral composition;

1.8. Any of the compositions described above, where the film thickness varies from 0.0254-0.102 mm (1-4 mils), for example, about 0.038-0.127 mm (1.5-5 mils) or about 0.051 mm (2 mils);

1.9. Any of the compositions described above, wherein the film fragments further comprise a humectant such as propylene glycol and / or a surfactant such as Polysorbate 20;

1.10. Any of the compositions described above, where the particles are of such a size that more than 90% passes through a 50 mesh filter or pieces of film pass through a filter from 30 to 100 mesh, or from 30 to 80 mesh, or from 50 to 100 mesh;

1.11. Any of the compositions described above, wherein the dissolution rate is from about 1 to 30 seconds, or from about 1 to 25 seconds, or from about 1 to 20 seconds, or from about 2 to 15 seconds;

1.12. Any of the compositions described above, wherein the orally acceptable carrier polymer is a synthetic anionic polymer polycarboxylate;

1.13. Any of the compositions described above, wherein the orally acceptable carrier polymer is 1: 4 to 4: 1 copolymers of maleic anhydride or acid with another polymerizable ethylenically unsaturated monomer;

1.14. Any of the compositions described above, wherein the orally acceptable carrier polymer is a methyl vinyl ether / maleic anhydride copolymer having an average molecular weight (M.W.) of from about 30,000 to about 1,000,000, for example, from about 300,000 to about 800,000;

1.15. Any of the compositions described above, wherein the orally acceptable carrier polymer is about 1-5%, for example, about 2% by weight of the composition;

1.16. Any of the compositions described above, which further comprises an effective amount of fluoride, for example, where the fluoride is a salt selected from tin fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, aminofluoride (e.g., N'-octadecyl trimethylenediamine N, N, N'-Tris (2-etaeol) dihydrofluoride), ammonium fluoride, titanium fluoride, hexafluorosulfate, and combinations thereof;

1.17. Any of the compositions described above, including L-arginine in free or orally acceptable salt form;

1.18. Any of the compositions described above containing buffering agents, for example, sodium phosphate buffer (for example, monobasic sodium phosphate and disodium phosphate);

1.19. Any of the above compositions comprising a humectant, for example, selected from glycerol, sorbitol, propylene glycol, polyethylene glycol, xylitol, and mixtures thereof;

1.20. Any of the preceding compositions that further comprises an abrasive or particles;

1.21. The immediately preceding composition, in which the adhesive or particles are selected from sodium bicarbonate, calcium phosphate (e.g. dicalcium phosphate dihydrate), calcium sulfate, precipitated calcium carbonate, calcium pyrophosphate, silicon dioxide (e.g. hydrated silicon dioxide), iron oxide, alumina, perlite , plastic particles, for example, polyethylene, and combinations thereof;

1.22. Any of the preceding compositions, comprising an abrasive in an amount of from about 15% to about 70% by weight of the total weight of the composition;

1.23. Any of the preceding compositions comprising one or more surfactants, for example, selected from anionic, cationic, zwitterionic and nonionic surfactants and mixtures thereof, for example, containing an anionic surfactant, for example, a surfactant selected from sodium lauryl sulfate, sodium lauryl sulfate ester and mixtures thereof, for example, in an amount of from about 0.3% to about 4.5% by weight;

1.24. Any of the preceding compositions, further comprising a viscosity modifying amount of one or more polymers selected from polyethylene glycols, polysaccharides (e.g., cellulose derivatives, e.g. carboxymethyl cellulose, polysaccharide rubbers, e.g., xanthan gum, carrageenan) and combinations thereof;

1.25. Any of the preceding compositions in the form of a dentifrice, mouth rinse, chewing gum or lozenge;

1.26. Any of the preceding compositions, further comprising a flavor, fragrance and / or tint;

1.27. Any of the preceding compositions further comprising water;

1.28. Any of the above compositions comprising one or more bactericidal agents, for example, containing a bactericidal substance selected from halogenated diphenyl ether (e.g. triclosan), extracts of medicinal herbs and essential oils (e.g. extracts of rosemary, tea, magnolia, thymol, menthol, eucalyptol, geraniol, carvacrol, citral, ginokitol, catechol, methyl salicylate, epigallocatechin gallate, epigallocatechin, gallic acid, miswack extract, buckthorn buckthorn extract), bisguanidine antiseptics (e.g. chlorhec sidine, alexidine and octenidine), quaternary ammonium compounds (for example, cetylpyridinium chloride (CPC), benzalkonium chloride, tetradecylpyridine chloride (TPC), N-tetradecyl-4-ethylpyridine chloride (TDEPC)), phenolic antiseptics, octenidine, hexenidine povidone iodine, delmopinol, salifluor, metal ions (e.g. zinc salts, e.g. zinc citrate, tin salts, copper salts, iron salts), sanguinarine, propolis and oxidizing agents (e.g. hydrogen peroxide, buffered sodium peroxyborate or peroxycarbonate), phthalic monopertal acid and its salts to slot, its salts and ascorbyl esters oleoilsarkozin, alkyl sulfate, dioctyl sulfosuccinate, salicylanilide, domiphen bromide, delmopinol, octapinol and other piperidino derivatives nitsina drugs, salts of chlorous acid; and mixtures of any of the above substances; for example, containing triclosan or cetylpyridinium chloride;

1.29. Any of the preceding compositions further comprising an additional whitening agent, for example, selected from the group consisting of peroxides, metal chlorides, perborates, percarbonates, peroxyacids, hypochlorites, and combinations thereof;

1.30. Any of the preceding compositions additionally containing hydrogen peroxide or a source of hydrogen peroxide, for example, urea peroxide or a peroxide salt or complex (for example, salts such as peroxyphosphate, peroxycarbonate, perborate, peroxysilicate or persulfate; for example, calcium peroxyphosphate, sodium perborate, sodium peroxycarbonate sodium peroxyphosphate and potassium persulfate);

1.31. Any of the preceding compositions additionally containing a substance that prevents the attachment of bacteria or prevents it, for example, solbrol or chitosan;

1.32. Any of the preceding compositions, further comprising a calcium and phosphate source selected from (i) calcium glass complexes, for example, calcium sodium phosphosilicates, and (ii) calcium-protein complexes, for example, casein phosphopeptide - amorphous calcium phosphate;

1.33. Any of the preceding compositions further comprising a soluble calcium salt, for example, selected from calcium sulfate, calcium chloride, calcium nitrate, calcium acetate, calcium lactate, and combinations thereof;

1.34. Any of the preceding compositions, optionally containing physiologically or orally acceptable potassium salts, for example, potassium nitrate or potassium chloride, in an amount effective to reduce dentin sensitivity;

1.35. Any of the preceding compositions further comprising an oral freshener, fragrance or flavor;

1.36. Any of the preceding compositions effective after application to the oral cavity, for example with a freshener, will (i) reduce tooth hypersensitivity, (ii) reduce plaque, (iii) reduce or inhibit demineralization and promote remineralization of teeth, (iv) inhibit the formation of microbial biofilms in the oral cavity, (v) reduce or inhibit gingivitis, (vi) promote healing of wounds or cuts in the mouth, (vii) reduce levels of acid-forming bacteria, (viii) increase relative levels of non-cariogenic and / or non-plaque bacteria, (ix) reduce or inhibit the formation of dental caries, (x) reduce, repair, or inhibit precarious enamel damage, for example, as detected by quantitative light-induced fluorescence (QLF) or electrical cariosis (ECM), (xi) treat, facilitate or reduce dry mouth, (xii) clean teeth and oral cavity, (xiii) reduce erosion, (xiv) whiten teeth; and / or (xv) promote the health of the whole organism, including the cardiovascular state, for example, by reducing the potential for systemic infection through the tissues of the oral cavity;

1.37. A composition obtained or obtained by combining ingredients as described in any of the preceding compositions;

1.38. Any of the preceding compositions that does not contain Gantrez® (copolymers of maleic anhydride with methyl vinyl ether);

1.39. Any of the preceding compositions, optionally containing effective amounts of additional components selected from fluoride, l-arginine in free form or in the form of an orally acceptable salt, bactericidal agents in addition to gallium salt and diamino acid polymer, anti-inflammatory agents and bleaching agents;

1.40. Any of the preceding compositions in which the composition is a toothpaste or mouthwash, optionally additionally containing one or more components such as water, abrasives, surfactants, blowing agents, vitamins, polymers, enzymes, moisturizers, thickeners, antimicrobials, preservatives, flavors, colorants and / or combinations thereof;

1.41. Any of the preceding compositions, wherein the composition is a toothpaste.

[70] All references cited in this document, therefore, include in its entirety all the information presented in these materials. If there is a conflict in the use of a word or term in the present description and documents that may be incorporated into this description by reference, the definitions corresponding to the present description should be adopted.

[71] As is customary everywhere, ranges are used as abbreviations to describe each and every value that is within a range. Any value within the range can be selected as the limit of the range. In addition, all references cited in this document, thereby include in its entirety all the information presented in these materials. If there is a conflict in the use of a word or term in the present description and documents that may be incorporated into this description by reference, the definitions corresponding to the present description should be adopted.

[72] Unless otherwise indicated, all percentages and quantities indicated in this document and elsewhere in the document refer to percent by weight.

EXAMPLES

Example 1

[73] Prepared simple solutions in water, composed of a 2% polymer precipitation stimulator and 0.05% blue pigment 15. The pH was adjusted to pH 7 to simulate the pH in the oral cavity during use of the product.

[74] The polymeric deposition stimulators tested were hydroxypropyl methyl cellulose (HPMC-Methocel E5), polyvinylpyrrolidone (PVP K-90) and Gantrez S-97.

[75] Experimental procedure for evaluating the retention of blue pigment from a solution on teeth. The roots of the third human molars were removed, and the tooth was divided in half from top to root. Both halves of the tooth were fixed in the cuvette with a warm impression mass, with the enamel side facing out. Stains from the tooth surface were removed by brushing with control silica toothpaste (10 min brushing with a suspension of 1: 2 (m / m), 120 wires / min). The tooth was again rinsed with deionized water, and cold air was used to remove excess water. Color was measured by a spectrophotometer (Spectroshade Micro, MHT technologies). Then the tooth was soaked in saliva for 15 minutes, after which the saliva was removed. To measure blue retention, 10 g of a simple solution was loaded into the cuvette. Teeth were soaked for 2 minutes. Then the solution was washed with 100 ml of deionized water and the excess water was removed using cold air. After that, the color was measured with a spectrophotometer. Δb * indicates a change from yellow to blue, a negative value indicates a shift towards blue. This indicator represents a measure by which the deposition of blue pigment can be quantified. Δb * is defined as the difference between the b * value of a tooth after stain removal from the surface and the value after soaking in a product containing blue pigment.

[76] The data in Table 1 indicate the absence of a correlation between high molecular weight and the deposition of blue pigment by the polymer, as claimed in European patent 1935395 A1. An important role in the ability of the polymer to deposit a hydrophobic substance on the teeth can be played by other factors, such as chemical functionality and solubility in water. Despite its large molecular weight, PVP delivers blue pigment to teeth no better than HPMC.

[77] Example 2

[78] Preparation of dentifrice composition.

[79] Films were prepared containing blue pigment, specifically blue pigment 15. The only film forming material in the composition was the HPMC polymer, specifically the one sold under the trademark Methocel E5 by Dow Corning. Methocel E5 is a low molecular weight HPMC and the viscosity of a 2% solution at 20 ° C and 10 s ^-1 is 4-6 mPa⋅s.

[80] After preparation, the films were cut into squares or ground into small fragments. These small pieces were included in the dentifrice, the full composition of which is shown in column A of Table 3.

[81] Experimental procedure for evaluating the retention of blue pigment on teeth from a dentifrice: The roots of third human molars were removed and the tooth was divided in half from apex to root. Both halves of the tooth were fixed in the cuvette with a warm impression mass, with the enamel side facing out. Stains from the tooth surface were removed by brushing with control silica toothpaste (2 min brushing with a suspension of 1: 2 (m / m), 120 wires / min) or with a preventative sanitation tool (application 5 s). The teeth were rinsed with deionized water, and cold air was used to remove excess water. Color was measured by a spectrophotometer (Spectroshade Micro, MHT technologies). To measure blue retention, 6 samples of toothpaste were loaded into the cuvette. 12 ml of deionized water or saliva were added to the cuvette. Teeth were brushed for 2 minutes at 120 runs per minute and a force of 250 g was applied to the cleaning machine. Then the toothpaste was washed off using 100 ml of deionized water and cold air was used to remove excess water. After that, measurements were carried out with a spectrophotometer. Δb * indicates a change from yellow to blue, a negative value indicates a shift towards blue. This indicator represents a measure by which the deposition of blue pigment can be quantified. Δb * is defined as the difference between the b * value of the tooth after removing stains from the surface and the value after cleaning with a product containing blue pigment. You can also register a change in whiteness index (WIO) to demonstrate that the deposition of blue pigment leads to an increase in the brightness of the tooth.

[82] The results presented in Table 5 demonstrate that the supply of blue pigment from dentifrice containing the blue pigment in the film consisting of HPMC polymer is greater than the supply of blue pigment from dentifrice without a film.

[83] The results presented in Table 5 show that the supply of blue pigment from various sizes of HPMC films is on par with the supply of blue pigment from a composition containing gantrez polymer. In addition, the supply of blue pigment led to an increase in whiteness, as indicated by a positive change in the whiteness index of WIO. A composition containing blue pigment and gantrez polymer is sold under the trade name Signal White Now, and it has been clinically reported to supply blue pigment in vivo to measurably increase tooth whiteness (Joiner, 2008). The results presented in Table 5 also show that the HPMC polymer is able to deliver blue pigment to the teeth if it is included in the dentifrice. However, it was found that the ability of the receiver array to deliver the blue pigment increases if the receiver array is pre-mixed and concentrated with the blue pigment in the film tape. The blue pigment and the HPMC remain together in the film until they are cleaned when the film tape dissolves. In Table 5, composition A variants having films with HPMC and blue pigment (50 mesh) provide whitening superior to composition C. A statistical comparison was made using a student T-Test, in which p <0.05 indicates a statistically significant difference between products.

[84] Example 3

[85] Dissolution rate

[86] The dissolution rate of toothpastes, including patches of a film of the invention, containing a blue pigment and having a film thickness of 0.051 mm (2 mil) and a particle size such that more than 90% of the particles pass through a 50 mesh filter, was tested under natural conditions. As can be seen in Table 6, the average dissolution time before the first appearance of color was 13.6 seconds.

Claims (18)

1. Teeth whitening composition for oral hygiene, including: (i) flakes of a water-soluble whitening film, which includes (a) a film-forming polymer containing hydroxypropyl methylcellulose, a viscosity of 2% solution at 20 ° C and 10 s ^-1 , which is 4-6 mPa · s, as measured using a Ubbelohde capillary viscometer; and (b) a pigment of blue or bluish-violet color, with a color tone angle in the CIELAB system in the range from 220 to 320 degrees, (ii) an orally acceptable carrier, where the particle size of the film flakes is such that more than 90% of the particles pass through a 30-50 mesh filter. 2. The composition according to p. 1, characterized in that the hydroxypropyl methyl cellulose is a low molecular weight hydroxypropyl methyl cellulose. 3. The composition according to p. 1 or 2, characterized in that the flakes of the film comprise from 0.01 to 5%, or from 0.015 to 5%, or from 0.015 to 3% by weight of the composition. 4. The composition according to any preceding paragraph, characterized in that the film does not contain starch. 5. The composition according to any preceding paragraph, characterized in that the low molecular weight hydroxypropyl methylcellulose is Methocel E5. 6. The composition according to any preceding paragraph, characterized in that the pigment is a Blue Pigment # 15. 7. A composition according to any one of the preceding paragraphs, characterized in that the flakes of the film further comprise a humectant and / or surfactant. 8. A composition according to any one of the preceding paragraphs, characterized in that the orally acceptable carrier comprises a synthetic anionic polymeric polycarboxylate. 9. A composition according to any one of the preceding paragraphs, characterized in that the orally acceptable carrier comprises methyl vinyl ether / maleic anhydride having an average molecular weight of from 30,000 to 1,000,000. 10. The composition according to any one of the preceding paragraphs, characterized in that the orally acceptable carrier is 1-5% by weight of the composition. 11. The composition of claim 1, further comprising an effective amount of additional agents selected from fluoride, arginine in a free or orally acceptable salt form, an anti-inflammatory agent, a bleaching agent, and a combination of two or more of these substances. 12. The composition according to p. 1, in the form of a dentifrice, mouth rinse, chewing gum or lozenges. 13. The composition according to p. 1, characterized in that the composition is a toothpaste comprising one or more of such components as water, abrasive, surfactant, blowing agent, vitamin, polymer, enzyme, moisturizer, thickener, antimicrobial agent, a preservative, flavoring, coloring and / or a combination of two or more of them. 14. A method for temporarily whitening teeth, comprising applying an effective amount of a composition according to any preceding paragraph, to the oral cavity of a subject who needs it.